A tool to facilitate dialogue with a range of relevant stakeholders, to help identify evidence considerations of policy makers.

In many cases, the end goal of clinical research is a change in policy; but there is often a gap between research design and policy needs, which can lead to wasted money and time. The Target Policy Profile (TPoP) tool was developed to address this common and critical issue. The TPoP tool can be used prior to research to identify key evidence needed to support policy decisions and/or at the point of evidence generation and dissemination. The TPoP can help researchers structure engagement with stakeholders to analyze the evidence underlying a given policy, the gaps in that evidence, and the nature of additional evidence needed. The TPoP also aims to facilitate early and ongoing communication between researchers, policymakers, and other global health stakeholders, such as manufacturers and regulators, to name just two. Armed with this knowledge and these relationships, clinical researchers can maximize the likelihood that studies are informative and support the efficient generation of optimal policies.

Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.